Effects of Telemonitoring and Telemedicine Service for Hypertensive Care
- Conditions
- Hypertension
- Interventions
- Procedure: Telemonitoring & TelemedicineProcedure: TelemonitoringOther: control group
- Registration Number
- NCT01335984
- Lead Sponsor
- Chang Hee, Lee
- Brief Summary
This is a multi-centered, randomized, parallel group, interventional \& open label clinical trial accessing efficacy of intervention effect by smart care system over existing treatment group for lowering blood pressure of hypertension patients taking anti-hypertension drug.
- Detailed Description
1. Objectives : To evaluate superiority in blood pressure lowering effect of the Smart Care Service compared to the conventional treatment in hypertensive patients receiving any conventional antihypertensive medication
2. Test and control group
* Control group : The subject group who is receiving any conventional treatment (hospital visit).
* Test groups
Conventional treatment + remote monitoring group:
The subject group who is receiving the health care services using conventional treatment (hospital visit) and remote monitoring.
Remote visit + remote monitoring group:
The subject group who is receiving remote visit and remote monitoring using videotelephony
3. Target Subject: Hypertensive patients receiving any conventional antihypertensive medication
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
-
Male and female patients who are able to receive outpatient treatment from over 20 to under 70 years of age.- Over SBP 140mmHg without diabetes or renal failure
-
Patients who are taking more than one kind of any antihypertensive medications
- Systolic blood pressure (SBP) ≥ 140mmHg in patient with diabetes mellitus and renal disease or
- Systolic blood pressure (SBP) ≥ 130mmHg in patient without diabetes mellitus and renal disease
-
Patients who are able to understand the purpose of this trial and to read and write
-
Patients who are able to use Smart Care PC for this trial
-
Patients who participate voluntarily and sign the informed consent
- Patients with severe hypertension (mean of two seated SBP ≥200 mmHg) at screening visit blood pressure measurement.
- Patients with secondary hypertension.
- HbA1c>11%.
- Patients are currently being hospitalized or planning to hospitalize due to hypertension.
- Patients with severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
- Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
- Patients who have been suffered cardiac infarction or severe coronary artery disease within 6 months, or with clinically significant congestive heart failure or heart valve defects.
- Patients with phthisis, autoimmune disease or connective tissue disease.
- Patients on medication therapies which may interfere with their blood pressure.
- Patients with known history of allergic reaction or contraindication to angiotensin II antagonists.
- Pregnant or lactating woman.
- Patients with known history of alcoholism, mental illness, or drug dependency.
- Patients who have participated in other study within 12 weeks prior to screening visit.
- Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemonitoring & Telemedicine group Telemonitoring & Telemedicine The subjects who are assigned in the Telemonitoring \& Telemedicine group should perform body composition measurement with self blood pressure measurement, and shall transmit the results to the Smart Care Serve via Smart Care PC. Telemonitoring \& Telemedicine group take remote medical treatment through video telephone instead of visiting study site. Telemonitoring group Telemonitoring The subjects who are assigned in the Telemonitoring group should perform body composition measurement with self blood pressure measurement, and shall transmit the results to the Smart Care Serve via Smart Care PC. Telemonitoring group require site visit once per 2 months (8weeks) Control group control group The subjects who are assigned in the Control group require site visit once per 2 months (8weeks)
- Primary Outcome Measures
Name Time Method Clinic blood pressure 24 weeks blood pressure value when hospital visiting
* Clinic blood pressure
* Changes in mean SBP(Systolic Blood Pressure) from baseline to 24 weeks visit
- Secondary Outcome Measures
Name Time Method Clinic blood pressure-Diastolic Blood Pressure(DBP) 24 weeks Changes in mean Diastolic Blood Pressure(DBP) from baseline to 24 weeks visit
Percentage of subjects who achieved goal clinic blood pressure 24 weeks Percentage of subjects who achieved blood pressure under 140/90mmHg at 24 weeks visit (under 130/80mmHg in subjects with diabetes mellitus and renal disease)
24 hours ABP(Ambulatory Blood Pressure) 24 weeks * BP measured at baseline and after administration of antihypertensive drugs at 24 weeks
* Mean values of 24 hours blood pressure (SBP / DBP) will be used for analysisPercentage of subjects who achieved 24 hours ABP(Ambulatory Blood Pressure) goal 24 weeks * Percentage of subjects who achieved average daytime BP of 24hrs ABPM under 135/85mmHg (under 130/80mmHg in subjects with diabetes mellitus and renal disease)
* Average daytime BP will be calculated with average of each hourly mean from 07:00 to 22:59 of the Clock timeSelf blood pressure measurement 24 weeks Mean value of each week of self blood pressure measurement (Systolic/Diastolic) from baseline to 24 weeks
Medication compliance 24 weeks * Patients diary will be recorded and medication compliance will be calculated by calculating the number of days administered antihypertensive drugs during the study
* Drugs compliance = the number of days administered antihypertensive drugs / participated period in this study \* 100%Reduction of body mass index 24 weeks Changes of Body Mass Index(BMI)
- Body Mass Index(BMI)=Body weight (kg)/Height2(m) from baseline to 24 weeksAssessment of patients' satisfaction 24 weeks Only remote monitoring group and remote visit + remote monitoring group are applicable
Trial Locations
- Locations (3)
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Yonsei University Health System
🇰🇷Seoul, Korea, Republic of